Intraoral scanner sleeve authentication and identification

ABSTRACT

Apparatuses, including sleeves, intraoral scanning systems to use these sleeves, and methods of using the sleeve, that authenticate the sleeve for use with an intraoral scanning system. Authentication may include verifying that the sleeve is new (unused) and/or verifying that the sleeve is appropriate and/or intended for use with the intraoral scanning system. Once authenticated, operation parameters of the intraoral scanning system can be automatically set based on information from a scanned identifier on the sleeve.

CLAIM OF PRIORITY

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/830,336 titled “INTRAORAL SCANNER SLEEVE AUTHENTICATION” filed onApr. 5, 2019, and U.S. Provisional Patent Application No. 62/955,662,filed on Dec. 31, 2019, titled “INTRAORAL SCANNER SLEEVE AUTHENTICATIONAND IDENTIFICATION,” each of which is incorporated herein in itsentirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The apparatuses and methods described herein may relate to protectivesleeves for optical scanners, and particularly for authentication ofoptical sleeves for intraoral scanner that may be useful in scanning theintraoral cavity for diagnosis, treatment, longitudinal tracking, toothmeasurement, and detection of dental caries and cracks.

BACKGROUND

Many dental and orthodontic procedures can benefit from accurate imaging(including, but not limited to accurate three-dimensional, 3D, imaging,2D imaging, surface scanning, florescent scanning, etc.) to providedigital descriptions of a patient's dentation and intraoral cavity. Anintraoral scanner may provide such imaging. Typically an intraoralscanner may include a hand-held sensing component for scanning withinthe patient's oral cavity. The hand-held component may be referred to asa wand, and may include one or more windows for transmitting and/orreceiving light to form images from within the patient's oral cavity.

Because the intraoral scanners may be inserted at least partially intothe patient's mouth, a protective element, referred to herein as asleeve or as a protective sleeve, may be used with the wand. The sleevecan act as barrier between the wand and the patient to protect thepatient from cross-contamination. Thus, the sleeve may be removable fromthe wand so that the sleeve can be replaced before using the wand withthe next patient. However, it may be difficult to keep track of whethera certain sleeve is new or has already been used. In addition, theoptical qualities and the shape and size of the sleeves may affect theperformance of the intraoral scanner. For example, if the sleeve doesnot fit on the intraoral scanner properly or does not have good opticaltransmission properties, the intraoral scanner will not obtain a goodscan of the patient's mouth, resulting in inaccurate scan results.

Described herein are methods and apparatuses, including protectivesleeves, systems including protective sleeves, and methods of using themto address these problems and that may enhance the safety andfunctionality of intraoral scanners.

SUMMARY OF THE DISCLOSURE

Described herein are apparatuses, including sleeves, intraoral scanningsystems to use these sleeves, and methods of using the sleeve, thatauthenticate the sleeve for use with an intraoral scanning system.Authentication may include verifying that the sleeve is new (unused)and/or verifying that the sleeve is appropriate and/or intended for usewith the intraoral scanning system.

Generally described herein are sleeves for an intraoral scanner that areconfigured to indicate use and/or identity of the sleeve; for exampledescried herein are sleeves for an intraoral scanner that include one ormore identifiers that may be used by the intraoral scanner to verify theidentity of the sleeve and/or the use state of the sleeve (e.g., asnew/original and/or unused). The sleeve may be tracked, includingindicating is origin, its expiration, and any properties of the sleeve,including its compatibility with a particular intraoral scanner or classof intraoral scanners. In some variations the sleeves described hereinare configured to modify the intraoral scanner, includingpreventing/permitting scanning, adjusting scanning parameters, etc.

For example, described herein are sleeves (e.g., protective sleeves) foruse with an intraoral scanner that include: a sleeve body configured tofit onto a wand of an intraoral scanner; a window through the sleevebody formed of a transparent material, wherein the window is configuredto align with a field of view of the intraoral scanner; and anidentifier on the window, wherein the identifier is configured toimpinge into the field of view of the intraoral scanner when the sleeveis attached to the intraoral scanner, further wherein the identifieridentifies one or more of: the identity of the sleeve and the use statusof the sleeve.

The identifier may be one or more of: an alphanumeric code, a logo, asymbol, a QR code, a bar code, hologram, etc. Any type of code (e.g.,any type of QR code, such as model 1, model 2, MiroQR code, iQR code,etc.) may be used. The may be positioned on the window in any location,including, for example, on a position that is spaced from an edge of thewindow, e.g., by at least 0.1 mm (e.g., at least 0.2 m, 0.3 mm, 0.4 mm,0.5 mm, 0.7 mm, 1 mm, 1.2 mm, 1.5 mm, etc.). Any of the identifiersdescribed herein may comprise a use-sensitive material, such as acomposition that reacts with and changes when exposed to one or more oflight (e.g., a wavelength of light emitted by the scanner, such as byphoto bleaching), moisture (e.g., due to the moisture of a patient'sbreath), carbon dioxide (e.g., changing color due to the patient'srespiration, and/or exposure to air, etc.).

Any of the identifiers described herein may be printed onto the window,on either the top and/or bottom surface of the window. Also describedherein are sleeves in which an identifier is formed on an inner and/orouter surface of the sleeve instead or in addition to on the sleevewindow.

In some variations an identifier may be printed onto the window in amaterial that is visible only when illuminated by light outside of thevisible spectrum (e.g., when illuminated by a florescent wavelength, byan IR/near-IR wavelength, etc.).

Alternatively or additionally, the identifier may comprise one or moreof a notch or protrusion in the edge of the sleeve body extending intothe window (e.g., within the field of view of the scanner).

In general, the sleeve body may configured to be worn over the wand,and/or attached to the end of the wand.

Also described herein are intraoral scanning systems. Any of thesesystems may be configured to include an intraoral scanner and one ormore sleeves that are configured to be used with the intraoral scanner;the intraoral scanner is generally configured to detect/authenticate thesleeve to confirm that the sleeve is new (e.g., unused) and/orappropriate for use with the intraoral scanner. For example, anintraoral scanning system may include: an intraoral scanner comprising awand having a transmission window for transmitting and/or receivinglight to form images from within the patient's oral cavity and aprocessor, the transmission window having field of view; and a sleeveconfigured to be worn on the wand, the sleeve comprising a sleeve body,a sleeve window through the sleeve body, the sleeve window configured toalign with the transmission window, and an identifier on the sleevewindow and configured to impinge into the field of view so that theintraoral scanner may image the identifier when the sleeve is worn onthe wand; wherein the intraoral scanner is configured to authenticatethe sleeve by scanning the identifier.

In general, the system may be configured to limit or prevent operationof the intraoral scanner until the sleeve is authenticated (e.g., untilthe sleeve is authenticated as new/unused).

Any of these systems may include a database either locally and/orremotely to determine the status (e.g., used/unused, expired, region,etc.) of a sleeve indexed by an identifier associated with the sleeve.The database may be, for example, a remote database comprising a listingof identifiers including the identifier on the sleeve window, furtherwherein the remote database further comprises information about thesleeve associated with the identifier on the sleeve window.

Any of these systems may include a processor that is configured toauthenticate the sleeve periodically during operation of the intraoralscanner (optionally, the system may be configured to prevent operationunless and until the sleeve is authenticated). The processor may includesoftware/hardware/firmware that determined the status and/or identity ofthe sleeve, e.g., by analyzing the scans from the wand at a regionassociated with the sleeve window, or otherwise, and by identifying anidentifier associated with the sleeve, applying logic to determine ifthe sleeve is unused/used and/or modifying operation of the scannerbased on the status and/or identity of the sleeve.

The identifier may be any of the identifier described herein (e.g., oneor more of: an alphanumeric code, a hologram, a logo, a symbol, a QRcode, or a bar code, etc.).

Also described herein are methods of operating an intraoral scanner toverify the status of a sleeve as described herein. For example,described herein are methods of operating an intraoral scanner, themethod comprising: scanning an identifier associated with a sleeveconfigured to be worn on a wand of an intraoral scanner; using theidentifier to verify that the sleeve is unused and/or authenticated foruse with the intraoral scanner; and suspending operation of theintraoral scanner until the verification confirms that the sleeve isunused and/or authenticated for use with the intraoral scanner.

For example, a method of operating an intraoral scanner may include:scanning, using a wand of the intraoral scanner, an identifier of asleeve, wherein the identifier is located on a sleeve window andimpinges into a field of view of the intraoral scanner when the sleeveis worn on a wand; verifying that the identifier is authenticated forthe intraoral scanner, wherein verifying comprises confirming that thesleeve is unused prior to scanning a patient's dental arch with theintraoral scanner; and preventing the intraoral scanner from scanningthe patient's dental arch until the verification confirms that thesleeve is authenticated.

Scanning may be performed when the sleeve is attached to the wand usingthe wand of the intraoral scanner to scan the identifier on a windowthrough the sleeve. Alternatively, scanning may be performed prior toattaching the sleeve (e.g., by scanning the sleeve or a code associatedwith the sleeve with the wand and/or by manually entering a code (e.g.,identifier). For example, in some variations the identifier is on aportion of a window that is within the field of view of the intraoralscanner. In some variations, scanning comprises scanning a sticker onthe sleeve, wherein the sticker includes the identifier.

Scanning may comprise scanning the identifier as the sleeve is attachedto the wand, and/or before the identifier is attached and/or after thesleeve is attached.

In general, using the identifier to verify that the sleeve is unusedand/or authenticated for use with the scanner may comprise confirmingthat the sleeve is unused. Alternatively or additionally, using theidentifier may comprise looking the identifier up in a database toconfirm that the sleeve associated with identifier is approved for usewith the intraoral scanner (e.g., has the correct optical properties,has not expired, is approved for use within a geographic region, etc.).

Generally, using the identifier may comprise looking the identifier upin a database (e.g., a remote or local database, such as an on-scannerdatabase) to confirm that the sleeve associated with identifier isapproved for use with the intraoral scanner.

In any of these methods, using the identifier may comprise examining ause-sensitive material of the identifier to confirm that the sleeve isunused (e.g., looking for exposure to light from the scanner, lookingfor exposure to a patient, etc., breath, etc.). Alternatively oradditionally, using the identifier may comprise examining a surface of awindow through the sleeve, e.g., to determine wear on the surface(scratching, condensation history, etc.).

In general, the activity of the scanner may be modified based on thestatus of the sleeve. For example, the use of the scanner may besuspended. In some variations suspending comprises preventing scanningof a patient's dentition with the intraoral scanner until the sleeve isconfirmed as unused and/or authenticated for use with the intraoralscanner.

Any of the intraoral scanners described herein may also assist intracking the sleeve usage. For example, any of these systems may updatea database with a use status of the sleeve indexed by the identifier.

Any of the protective sleeves described herein may include a removableidentifier that can be separated from the sleeve before scanning thepatient's dentition. In one example, the removable identifier is on, orpart of, a window cover that covers the optical window of the sleeveprior to use. The window cover may be a protective cover that protectsthe window, for example, during storage or handling of the sleeve.

Any of the intraoral scanners described herein may also be configured tooperate under one or more use modes. The identifier of a sleeve mayinclude information associated with one or more particular use modes forthe scanner to operate when using the particular sleeve. The use modemay be based on physical characteristics of the sleeve and/or based ondesired permissions of the user using the sleeve. The use mode of anintraoral scanner may be automatically set when the scanner scans theidentifier.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is an example of one variations of an intraoral scanner asdescribed herein.

FIG. 2 illustrates the use of a protective sleeve with the example ofthe intraoral scanner as described herein. The sleeve may include anidentifier that is automatically or manually detected by the intraoralscanner for determining the use parameter(s) of the sleeve, including ifthe sleeve is used or unused and/or is appropriate for use with theintraoral scanner.

FIG. 3 illustrates another example of a system including a protectivesleeve and an intraoral scanner.

FIGS. 4A-4C illustrate perspective bottom and side views, respectivelyof a sleeve (e.g., protective sleeve) for an intraoral scanner. Any ofthese sleeves may include an identifier and/or a use-indicating materialas described herein.

FIGS. 5A-5B show examples of sleeves having an identifier (shown as asymbol in FIG. 5A and a QR code in FIG. 5B) on a sleeve window (offsetfrom the edge of the sleeve window and within a field of view of anintraoral scanner when the sleeve is applied to the intraoral scannerwand).

FIG. 6 is another example of a sleeve including an identifier that maybe detected by an intraoral scanner; the identifier in this example isconfigured as protrusions on the edge of the sleeve.

FIG. 7 illustrates one example of a method of operating an intraoralscanner including detecting a use parameter for a sleeve (e.g., directlyor through detection of an identifier associated with the sleeve) andmodifying the activity of the intraoral scanner based on the useparameter.

FIGS. 8A-8B illustrate examples of protective sleeves having windowcovers for protecting the windows and having scannable identifiers.

FIG. 9 illustrates an example of a QR code.

FIG. 10 illustrates another example of a method of operating anintraoral scanner including setting a use mode of the scanner based oninformation from a scanned identifier on a sleeve.

FIG. 11A is one example illustrating the operation of a system forauthenticating a sleeve for an intraoral scanner, in which a pluralityof sleeves are packaged in a container holding multiple sleeves; thecontainer may be scanned by the intraoral scanner prior to coupling oneof the sleeve to the intraoral scanner.

FIG. 11B is another example illustrating the operation of a system forauthenticating a sleeve for an intraoral scanner in which a singlesleeve is contained with a container.

FIG. 12A illustrates a method of authenticating a sleeve by scanning,using an intraoral scanner, a code (e.g., a QR code is shown) on anoutside of the sleeve prior to coupling the sleeve with the intraoralscanner.

FIG. 12B illustrates a method of authenticating a sleeve by scanning,using an intraoral scanner, a code on an inside of the sleeve as thescanner is coupled with the sleeve.

FIG. 12C illustrates another example of a method of authenticating asleeve by receiving orientation information as the scanner is insertedinto the sleeve; this information may indicate that the sleeve is beingapplied or removed, or other use information about the sleeve.

FIG. 13 illustrates another example of a method of authenticating asleeve using a marker in or on the sleeve that is detected by a sensoron the intraoral scanner.

FIG. 14 schematically illustrates one example of an intraoral scanningsystem configured to include and implement sleeve authentication asdescribed herein.

DETAILED DESCRIPTION

In general, described herein are protective sleeves for use withintraoral scanners. The protective sleeves may include a body portion,which may be configured to attach to a hand-held wand portion of anintraoral scanner, and a window portion through which the intraoralscanner may transmit light and/or receive images. The window portion maybe covered or uncovered. In particular, described herein are protectivesleeves configured to allow authentication as well as systems includingsuch sleeves that are configured to authenticate them and methods ofusing them.

As used herein the term authentication may include determining, by theintraoral scanner, the identity and/or characteristics of a sleeve to becoupled with the intraoral scanner. In some variations authenticationrefers to proving the identity of a sleeve or sleeves. In somevariations authentication include verifying that the sleeve is a valid,approved and/or compatible sleeve for use with the intraoral scanner. Insome variations, authentication include identifying if the sleeve hasbeen previously used (by the particular intraoral scanner and/or anotherintraoral scanner). In some variations authentication includesactivating and/or modifying the operation of the intraoral scanner inresponse to the sleeve.

A protective sleeve may be configured as a rigid, semi-rigid orcompliant body that may mate with a hand-held wand portion of anintraoral scanner. The body may be configured to extend over the wand;the protective sleeve may form a barrier against the transmission ofcontamination such as bacteria, viruses, and like. The body may beconfigured to act specifically as a barrier to saliva, mucus and otherbiological fluids. In some variations the protective sleeve, includingthe body of the protective sleeve, may be formed at least in part from apolymeric material, such as a silicone, latex or other polymer. The bodyof the sleeve may extend over the wand and/or all or some of a cord orcable. For example, the sleeve, including the window and body of thesleeve (also including any extension of the sleeve) may be formed of aflexible barrier material (e.g., a plastic or other polymeric material)that may provide a fluid and/or pathogen barrier.

The protective sleeve may include a window portion that is configured toalign with a corresponding window on the wand to transmit light and/orother information for forming images of the patient's dental cavity. Thewindow region may be sized and/or shaped to match or refine the imagingwindow of the wand. As will be described in some variations, below, thesleeve window may be sized and/or shaped so that at least a portion ofthe sleeve window projects or extends at least partially into the fieldof view of the imaging window of the wand, in order to aid inauthentication. The sleeve window may be formed of a transparentmaterial, and in particular may be formed of a material that istransparent to the one or more wavelength(s) used by the intraoralscanner for imaging the patient's dentition. For example, the sleevewindow may be formed of an optically clear material, or a material thatis transparent in the optical wavelengths and/or the fluorescentwavelength(s) being used and/or the near-infrared wavelengths. Thesleeve window may be formed of a material that is rigid or semi-rigidand may be a polymeric material, e.g., polycarbonate, polymethylmethacrylate (PMMA), polyethylene terephthalate (PET), amorphouscopolyesters, polyvinyl chloride (PVC), liquid silicone rubber (LSR),cyclic olefin copolymers, polyethylene (PE), ionomer resin, transparentpolypropylene (PP), fluorinated ethylene propylene (FEP), methylmethacrylate-acrylonitrile-butadiene-styrene (MABS, e.g., transparentABS), polystyrene (general purpose—GPPS), styrene methyl methacrylate(SMMA), etc. One or more material (including layers of materials) may beused. The sleeve window may be sealed to the body portion to perfect thebarrier against biological contamination. In some variations, all or aportion of the sleeve may also be formed of the same material as thewindow. In some variations the sleeve may be formed of a material thatis different from the window.

In general, the protective sleeve may mate with and engage the intraoralscanner. For example, the protective sleeve may be configured to cover ahand-held wand of an intraoral scanner. In some variations theprotective sleeve extends over the end of the hand-held wand so that thewindow of the protective sleeve aligns with the imaging window of thewand. The body of the protective sleeve may extend over the hand-heldwand and in some variations down the body of the wand some distance(e.g., 6 inches or more, 8 inches or more, 12 inches or more, 16 inchesor more, 2 feet or more, 3 feet or more, 4 feet or more, 5 feet or more,etc.).

In some variations the protective sleeve may also be textured forgripping (e.g. by a user's hand) securely when operating the intraoralscanner. The protective sleeve may also include one or more ridges,bumps, channels, textures, etc., to assist in gripping.

A protective sleeve comprises a housing configured to fit over a portionof an intraoral scanning device and protect the intraoral scanningdevice from an external environment. The intraoral scanning devicecomprises a first aperture for transmission of optical signals, thehousing defines a second aperture for transmission of the opticalsignals, and the second aperture is aligned with the first aperture whenthe housing is fit over the portion. The protective housing comprisesone or more supports attached to the housing and a transparent elementsecured by the one or more supports and aligned with the secondaperture. The transparent element is further aligned with a defoggingelement of the intraoral scanning device when the housing is fit overthe portion, and an external surface of the transparent element is toreceive heat generated by the defogging element to prevent fogging ofthe transparent element.

The protective sleeves described herein may include additional materialsand components, including lighting (e.g., one or more LEDs), sensors,circuitry, or the like, which may be embedded and/or held within theprotective sleeves.

Any of the protective sleeves and/or intraoral scanners described hereinare configured to permit authentication of a particular sleeve. Asmentioned, authentication may refer to authentication of the identity orcategory of the sleeve as preapproved for use with a particularintraoral scanner, which may confirm that the sleeve is appropriate foruse with that intraoral scanner as well as uniquely and/or categoricallyidentifying the protective sleeve for tracking, monitoring, andadjusting scanning parameters (e.g., imaging parameters, costparameters, etc.). In some variations authentication may includeidentifying and/or confirming the identity of a particular protectivesleeve, class of sleeve, type of sleeve, lot and/or batch of sleeves,etc. In some variations, authentication may include uniquely identifyinga particular protective sleeve. The identity of the particular sleevemay be used to track the protective sleeve, including monitoring the useof that sleeve for a particular patient. Alternatively or additionally,authentication may include confirming that a sleeve is a member of aparticular class or lot of sleeves; the class or lot of sleeves may beused to confirm that the protective sleeve(s) is being used with thecorrect intraoral scanner, that there are not issues (e.g., recalls) onthat class or lot, that the settings for the intraoral scanner arecorrect for use with the sleeve, etc.

Authenticating protective sleeves to be used by an intraoral scanner asdescribed herein may provide a number of significant advantages,including protecting the patient, user (e.g., doctor, dentist,orthodontist, dental technician, etc.) and/or the intraoral scanner. Forexample, in some variations authentication of a protective sleeve for anintraoral scanner may be done to ensure that a particular sleeve is usedwith a single patient, in order to prevent cross-contamination betweenpatients. For example, the sleeves and methods of authenticating themdescribed herein may ensure that only original (e.g., new, unused,and/or in some variations sterilized) sleeves will be used with theintraoral scanner. When authentication includes determining a uniqueidentifier of the protective sleeve, the intraoral scanning system mayread or receive (or determine) the unique identifier and may modify theoperation of the intraoral scanner to limit the operation of theintraoral scanner so that the particular, authenticated and identifiedprotective sleeve may only be used with a single patient.

In some variations the sleeve may include one or more indicators thatmay indicate that the sleeve has been used already and/or that thesleeve has been cleaned, such as sanitized, washed, autoclaved,sterilized, etc. For example the one or more indicators may indicatewhen a sleeve has been exposed to a high temperature for sufficient timeto sterilize the sleeve. In some variations this may be detected by anoptical change (e.g., a mark or marker that reacts to the hightemperature and/or humidity, etc. characteristic of sterilization). Forexample the one or more markers may be thermal exposure indicators,fluid/water exposure indicators, radiation indicators, etc.

Thus, authentication may include authenticating that the sleeve isunused and/or that the sleeve has been used and sterilized. In somevariations sleeves may be designated as single-use, as described herein.In some variations, the sleeves may be configured to be used more thanonce (e.g., twice, three time, four times, etc.). For example, a two-usesleeve may be used once (in some variations its use may be recorded onthe apparatus when initially authenticating it prior to or as it isapplied for use. Thereafter the sleeve may be cleaned and/or sterilizedand used for a second time; the sterilization may mark or triggermarking on the sleeve being sterilized, as mentioned above.

In some variations the sleeve may be authenticated with a unique codeand this code may be associated with a particular user, e.g., within adatabase of or accessibly by the intraoral scanner. Thereafter thesleeve may only be used with the user for which it is associated.

In some variations, the use of a sleeve as described herein may ensurethat the scan quality of the intraoral scanner remains high, since theidentified protective sleeve may be matched to the operation of theintraoral scanner. This may also help ensure clinical safety, preventingcontamination between patients. In some variations, the methods andapparatuses described herein may adjust the behavior of the intraoralscanner. In addition to turning on/off the scanner, e.g., only operatingthe intraoral scanner when an approved, and/or unused sleeve has beenauthentication on the wand, the systems and methods described herein mayalso or alternatively modify the behavior of the scanner by adjustingthe scanning parameters to accommodate characteristics (e.g., opticalproperties) associated with the sleeve and/or the intraoral scanner.

As will be described in greater detail below, the systems and methodsdescribed herein may allow local and/or remote authentication of theprotective sleeve. For example, in some variations the identity of aparticular sleeve may be determined using a local technique (e.g.,without requiring access to a remote server, database or the like).

Authentication of sleeves may allow an intraoral system to determine theorigin of the sleeve, including matching and enforcing a geographicregion or zone in which the sleeve is permitted to be used. For example,it is possible that regulatory rules of different countries, regions orstates may require limiting the operation of a sleeve to a singlepatient and/or a single session before a new sleeve must be applied. Byauthenticating and tracking a protective sleeve, a system may confirmthat that sleeve is appropriate for use in the region in which theintraoral scanner is being operated. Geographic region may be determinedby checking, for example, the local address and/or an internet IPaddress associated with the intraoral scanner or user of the scanneragainst permissions (and/or zone, region, etc. identifier) associatedwith the identifier of the protective sleeve.

As mentioned, any of the methods and apparatuses described herein may beconfigured so that authentication enables enforcement of a single use(e.g., single continuous use) of a sleeve with a scanner, and/or uselimited to a single patient. Alternatively, the methods and apparatusesdescribed herein may be configured to allow multiple uses. In somevariations the methods and apparatuses may be configured to detectcleaning and/or sterilization of the sleeve and may allow additionaluse(s) following cleaning and/or sterilization. The apparatuses (e.g.,systems, devices, etc.) described herein, including the intraoralscanners may be configured to include a particular case or patientassociated with a case as a scan is recorded. Interrupting the scan bymore than a predetermined period of time (e.g., one hour, two hours,four hours, six hours, 12 hours, 1 day, etc.), starting a new caseand/or ending or closing a patient session, may result in the systemlocking the use of the scanner for the current protective sleeve basedon the sleeve identity. Thus, the sleeve may be identified going forwardas “used”. In some variations, a used/unused tag may be associated witheach uniquely identified sleeve. Additional identifiers, including anidentifier associating the particular sleeve with a particular patient,a particular intraoral scanner, a particular geographic location, aparticular user, etc., may also or alternatively be used. Thus theauthentication may include associating one or more additionalidentifiers (use, patient, etc.) with the sleeve identifier in a localor remove (e.g., cloud-based) database or data store.

In some variations a count may be associated with each sleeve as anadditional identifier. For example, the count may indicate the number ofuses (e.g., a single use or uses), which may be used in some apparatusesto provide or limit the number of uses that a sleeve may be used. Forexample, the systems described herein may be configured to identify aparticular sleeve and permit that sleeve to be used on an intraoralscanner a pre-defined number of times.

In some variations a date and/or time, such as an expiration date, maybe associated, including as an additional identifier or as part of theunique identifier of the sleeve. In general, the identifier may be analphanumeric code that uniquely identifies the sleeve. Part of thealphanumeric code identifier may be based on the date and/or location inwhich the sleeve was manufactured, it's lot number, etc. An expirationdate may be calculated from this date information. Alternatively oradditionally, an expiration date and/or manufacturing date may beassociated as an additional identifier for the sleeve.

Authentication and/or identification of a sleeve may be used to mark ormodify a case and/or scans taken for a case. For example, the sleevesdescribed herein may be used for any scan type, and the identity of thesleeve used to take the scan(s) (e.g., sleeve identifier and/or anyadditional identifiers may be associated with the scan(s)) may beincluded, e.g., as metadata, with the case information, and/or all orsome of the scans taken with the case. Associating a scan with aparticular sleeve may allow tracking of errors associated with thesleeves, and/or may be used for commercial effects, includingassociating pricing of sleeves, and/or scans.

FIG. 1 illustrates one example of an intraoral scanner as describedherein. One example of an intraoral scanner 100 is the iTero® intraoraldigital scanner manufactured by Align Technology, Inc. In general, anintraoral scanner may include a hand-held wand 103, which may include anoptical system (including projection/imaging optics) comprising one ormore lenses and having an optical axis. The apparatus may also includeillumination optics. The apparatus can comprise an axial scanner (e.g.,a depth scanning module) that is configured to be move theprojection/imaging optics system along the optical axis. The apparatusmay include a beam splitter configured to transmit light from the lightsource (after passing through the pattern) to the object and reflectlight returning from the object onto an imaging sensor. Thus, theapparatus may include an image sensor configured to receive lightreturning from the object (via the projection/imaging optics) throughthe beam splitter. The apparatus can be configured for 3D scanning to atleast a portion of the object, for example, intraoral dental 3D scanningfor all derivatives of dental restorative and orthodontics indications.The apparatuses for confocal scanning disclosed here can include aconfocal illuminator. The optical system may include aprojection/imaging system or subsystem including projection optics andimaging optics. For example, the projection optics and the imagingoptics can be configured to share the same optical elements (lenses) andthe same optical path. The apparatus can comprise the depth scanningmodule, which comprise a compact linear actuator, for example, a voicecoil motor (VCM). The scanner can comprise a front tip, which caninclude a 45 degree (e.g., back-heated defogging) fold mirror.

The scanner may include one or more processors and may include on oremore illumination sources (LEDs, lasers, etc.). In FIG. 1, the hand-heldwand 103 also include a window 107 providing optical access into thescanner. The window may include an optically transparent cover. Thescanner may be wireless or wired to additional components of the system,including one or more additional processors. The scanner may generallyilluminate and/or image in the visible spectrum, in the infrared ornear-infrared spectrum, in the florescence spectrum, etc. A display 105may also be included as part of the system. The intraoral scanner shownin FIG. 1 may be used with one or more sleeves, as shown in FIGS. 2 and3.

In FIG. 2, the intraoral scanner 100 includes a protective sleeve 109that is placed over the hand-held wand 103, so that a sleeve window 111is aligned with the window in the scanner 107 (not visible in FIG. 2).FIG. 3 shows an alternative variation in which the sleeve 109 is longer,extending over the wand and connecting cable.

FIGS. 4A-4C illustrate one example of a protective sleeve 409 which maybe authenticated as described herein, including one or moreauthentication features. In FIG. 4A, the sleeve 409 is formed of asemi-rigid material, and is configured to be placed over a hand-heldwand of an intraoral scanner, as shown in FIG. 2. FIG. 4B shows thesleeve of FIG. 4A from a bottom view, showing the window 411 throughwhich optical transmission may occur. Finally, FIG. 4C shows a sideperspective view of the sleeve; the window 411 is on the bottom surface.

Any of the apparatuses and methods for authentication and/or tracking ofsleeves described herein may include authentication and/oridentification based impinging the field of view of the apparatus withan identification indicator. In some variations, the marking orindication may be included in the window of the sleeve.

Window-Based Authentication

Thus, in any of the apparatuses or methods described herein, anidentifier (which may include a symbol, letter, number, pattern, color,or any combination of these) that may uniquely or categorically identifythe sleeve for detection by the scanner, and in particular for directdetection by the hand-held wand and imaging portion of the scanner.Despite impinging in the field of view, the systems, including theintraoral scanning systems, described herein may automatically detectand verify (e.g., authenticate) the identifier and scan the patient. Forexample, in some variations the identifier may be an indicator in thewindow of the sleeve. The vision system of the scanner itself may thensee the indicator and determine if the sleeve is authenticated for use.The scanner may be configured to ignore the indicator for the purpose ofscanning. The verification can either happen at the beginning (e.g., atthe start of scanning) or multiple times during the scanning procedure(e.g., periodically at regular intervals, such as every few seconds,every minute, every 2 minutes, every 3 minutes, etc., at randomintervals, etc.).

FIGS. 5A and 5B illustrate examples of indicators marked onto the windowof the sleeve. In FIG. 5A the identifier is a graphical and textualmarker 505 resembling a logo that is positioned in a predefined regionof the window 511 of the sleeve. In this example, the indicator is inthe bottom right portion of the window of the sleeve and is configuredto impinge into the scanning field of view of the intraoral scanner whenthe sleeve is placed over the wand, e.g., so that the wand imagingwindow is aligned with the window in the sleeve.

FIG. 5B is another example of an identifier 507, shown here configuredas a QR code that includes information that may be uniquely linked tothe protector sleeve. In FIG. 5B the identifier (e.g., QR marker or anyor marker that includes identifying information) may be positioned on aportion of the sleeve that impinges into the field of view and may bedetected by the intraoral scanner. FIG. 9 shows a close-up view of anexample QR code.

In general, the location and/or orientation of the identifier may beused for authentication, and may be detected and/or verified by theintraoral scanner. As mentioned, the intraoral scanner may detect theidentifier in the field of view of the scanner and may be configured toimage the teeth through or around the marker, without significantlyimpacting the quality of scans.

As mentioned, any appropriate identifier may be used. The identifier maybe matched to the scanning functionality of the intraoral scanner.Specifically, the identifier may be in color (including in non-visiblecolor, such as IR/near-IR, florescent, etc.) and may be detected onlyupon illumination by the appropriate wavelength(s) of light anddetection by the intraoral scanner. Different regions of the identifiermay be in different colors, fonts, etc., which may provide additionalinformation for authentication. In general, the colors(s) and/or thesizes of the identifier may indicate the version, location, permissionsand etc. associated with the sleeve. In some variations the identifiermay be in a different color for portions of the identifier, and/ordifferent fonts may be used.

The identifier may include parts that are only visible when illuminatedby a specific wavelength or wavelengths of light emitted by the sensorthrough the window in the wand. For example, as mentioned above, theidentifier may be marked using a material that is only visible (or fullyvisible) when illuminated using a specific wavelength light e.g. near-IRlight (NIRI). Alternatively or additionally, the identifier may beformed at least in part of a material that is reflective for a specificwavelength.

Another form of directly scanned identification may include one or moreidentifier markings on either the sleeve and/or on the packaging and/oron packaging insert(s) accompanying the sleeve. For example, in somevariations the sleeve may include a making on the inside or outside ofthe sleeve that may be imaged before or during attachment of the sleeveto the wand.

In some variations, the sleeve may include an identifier that is presentin the inside of the sleeve that may be imaged by the intraoral scannerwhen attaching the protective sleeve to the wand. The protective sleevemay be attached to the intraoral scanner with the intraoral scanner ‘on’and scanning; scanning may detect the identifier in the intraoralscanner. The identifier may be formed, printed or otherwise attached toan inner surface of the sleeve, including but not limited to the windowof the sleeve and/or a region that is proximal to the window within thesleeve, so that it may be viewed by the intraoral scanner whenattaching. In some variations a sticker or other member including theidentifier may be attached to the inside of the intraoral sleeve.Alternatively in some variations the identifier may be pressed or formedinto the sleeve, including into the body portion of the intraoralscanner.

An intraoral scanner may be configured to include an attachment mode forattaching the protective sleeve, verifying both that the sleeve isattached and verifying that the sleeve is authentic (e.g., new and/orapproved for use with the intraoral scanner, etc.).

Any of the sleeves described herein may include an identifier one anoutside surface of the intraoral scanner that may be scanned by theintraoral scanner. For example, when turning the intraoral scanner on,the system may enter into a sleeve authentication mode, in which thescanner waits to receive (using the wand itself) an image or scan of theindemnifier before proceeding. Thus, if the identifier is attached,formed or otherwise an outer surface of the sleeve (including, but notlimited to, the window of the sleeve), then scanner may, within apredefined time for activating the intraoral scanner, detect when theidentifier and confirm authenticity and/or appropriateness of using thatsleeve with the scanner. In some variations this may then allow thescanner to proceed to preparing to scan the subject/patient. Asmentioned the identifier may be printed, formed or attached to theoutside of intraoral sleeve and may be directly scanned by the intraoralscanner wand either before, during, or after attaching the sleeve.

In some variations the identifier is packaged with the sleeve and may bescanned by the wand. For example, a paper, sticker, etc. may be markedwith the identifier for the sleeve and may be directly scanned by theintraoral scanner.

Any of the methods and apparatuses described herein may alternatively oradditionally use an identifier that is manually entered by the user intothe intraoral scanner to verify the sleeve, track use of the sleeveand/or adjust the operation of the intraoral scanner using the sleeve.For example, an identifier that includes a symbolic or an alphanumericcode may be entered into the scanner manually. The scanner may thenverify the identity and/or restrict or allow scanning using the sleeve.

In some variations, the identifier, including identifiers on all or aportion of the window may be used both as an identifier and as anoptical target for adjusting, setting and/or calibrating one or moreparameters of the intraoral scanner. For example, when the identifier ison the window, the identifier may be used to calibrate the intraoralscanner wand for more accurate scanning of the intraoral cavity (e.g.,teeth, gingiva, palate, etc.).

Types of Identifiers

In general, any appropriate identifier may be used. For example, whenalphanumeric identifiers are used, the alphanumeric identifier may beprinted in a specific color, font, etc. that also provides additionalinformation and/or verification.

Any of the identifiers described herein may include self-referencing inthe encoded information, in which the as encoded information is keyed sothat an analysis of the encoded key may provide an initial verificationthat the identifier is valid. This may be achieve by enclosing theidentifier using a technique similar to an error correcting code, inwhich the intraoral scanner may locally (e.g., without requiring accessto a remote database) confirm that the identifier is likely correct;more detailed information on the identity and actions taken with thesleeve may later be remotely retrieved and/or stored.

For example, the identifier may be configured so that it includesportions (e.g., blocks) that are, e.g., traditionally partitioned toinclude regions that code for checks to the information within theidentifier (e.g., block codes and/or convolutional codes, and/or turbocodes). These codes may allow for encoding and decoding algorithms thatmay be used to determine the likely veracity of the identifier read bythe apparatus. For example, the identifier may include a forward errorcorrection region; a portion of the identifier may be used by the localintraoral scanner (after being directly detected by the scanner and/orentered by a user into the scanner), to determine the likelihood thatthe rest of the identifier is accurate. A Hamming code is one example ofa linear binary code which may include additional characters that may beused to verify the accuracy of the other digits. Thus, even if theintraoral scanner is not connected to a remote server or is unable toconnect to a remote server reliably, it may at least initially verifythat an identifier corresponds to a legitimate protective sleeve. Theidentifier may be later confirmed as legitimate by accessing a remoteserver, remote database, etc.

In general, scans taken with an invalid (unverified or authenticated)protective sleeve may be later adjusted (e.g., marked as invalid, etc.).In variations in which the scan is tentatively (e.g., locally)identified as legitimate, but which later authentication indicates isnot authenticated may be adjusted, marked, deleted, or otherwiseindicated as coming from an invalid protective sleeve. Alternatively insome variations a failure of authentication does not stop the scanning,but merely results in marking of the scan(s) that it was taken with aninvalid protection sleeve.

Use Verification

In addition or as an alternative to the use of identifiers describedherein, any of these methods and apparatuses (e.g., systems, includingintraoral scanners, sleeves, etc.) may be configured to detect thepresence of a sleeve, as well as the prior use of a sleeve even with theuse of an identifier. An intraoral scanner, including, but not limitedto confocal intraoral scanners, may detect the presence of a sleevewindow by detecting the presence of even a visually transparent windowcovering the imaging window of the wand, even in the absence of anexplicit identifier. The scanner may be configured to scan the depth atwhich the sleeve window will be present when a sleeve is attached to thescanner and may detect reflections, scratches, and surface imperfectionsfrom the sleeve window. Such reflections and imperfections are typicallypresent even when a new and ‘clean’ sleeve is attached to the wand.

Thus, any of the systems described herein may automatically detect thepresence of a sleeve when worn on the wand by detecting and/orcharacterizing the sleeve window based on the reflections/imperfectionsarising due to the sleeve window. In some variations thecharacterization of the sleeve window when the system is initiallyactivated, e.g., to start a patient scanning system, may be examined todetermine that the sleeve window is characteristic of a new sleeveand/or may have characteristics corresponding to an authenticatedsleeve. For example, authenticated sleeves may be those that aresufficiently clean, smooth, non-reflective, etc. over one or morewavelengths to be used by the scanner. The intraoral scanner maytherefore be configured to initially scan the sleeve window itself(based on the expected location/depth of the sleeve window when attachedand/or based on a detection routine that identifies the depth of thesleeve window). The entire sleeve window may be examined and compared toexpected values to confirm that a sleeve is attached and/or that thesleeve window is characterized within approved parameters (e.g., fornew, authentic sleeves). For example, the analysis of the sleeve windowmay generate a value or set of values based on the examination(indicating reflectance, surface flaws, smoothness, scratches, surfacedeposits, etc.); this value or set of values may be compared to expectedvalues for an authenticated and/or ‘new’ sleeve.

For example, some systems may be configured to detect the use of a usedsleeve based on imaging and analysis of the sleeve window, including theouter surface of the sleeve window and/or a comparison between the innersurface of the sleeve window and the outer surface of the sleeve window.In some variations the outer surface of the sleeve window may accumulatematerial (saliva, condensations due to breath, etc.) and/or use markings(scratches, etc.) over time with use. Thus, by examining the sleevewindow (or in some variations a comparison between the outer surface ofthe sleeve window and the inner surface of the sleeve window), thesystem may determine or track use, and may identify when a used sleeveis attached to a wand; when a used sleeve is attached the system mayrequire removal and attachment of a new sleeve. Alternatively oradditional the system may request or determined a new sleeve after aparticular amount of use. Preventing the use of ‘used’ sleeves in thismanner may be done instead of, or in addition to, detecting anidentifier as described above.

In any of the sleeves described herein, the sleeve (e.g., sleeve window)may be coated, marked, formed from, or otherwise include a material thatchanges with use in a manner that may be detected by the intraoralscanner (use-sensitive materials). For example, in some variations themethod may include a marking and/or coating, e.g., on an outer surfaceof the sleeve window, with a material that reacts to exposure to airand/or breath exposes. Such materials may be include colorimetricmaterials that change color based on carbon dioxide and/or pH; forexample, a material that reacts with carbon dioxide from breach (such asbromothymol blue, calcium hydroxide, etc.) may change pH and or color; apH color indicator may also be used. This change in color may bedependent upon the amount of exposure to a patient's breath maytherefore be used to detect use of the sleeve by the intraoral scanner.The system may be configured to require a new sleeve at the start of apatient scanning session. In some variations, the marking material(e.g., color-changing indicator) may further be arranged into anidentifier (e.g., code, pattern, logo, etc.) that may be detected forverification even before use of the sleeve, as described above. Asmentioned, any combination of identifier categories may be used,including, for example, a combination of a logo and a code (e.g., a logowith a code, such as a QR code, embedded in it, etc.).

Other use-sensitive materials or markings may be included. For example,in some variations the sleeve window may include a material that changeswith exposure to light, including in particular the lights used forscanning. In some variations the use-sensitive marking may form or bepart of an identifier. Thus, use of the sleeve may modify theuse-sensitive marking/identifier (e.g., marking with a light-sensitivematerial) intentionally or with normal use, indicating that is has beenused. For example, the system may be configure to “mark” a sleeve bydirecting light to the use-sensitive marking. Examples of use-sensitivemarkings including materials that photobleach with exposure to one ormore wavelengths of light (e.g., florescent light, UV light,infrared/near-IR light, visible light, etc.). The use-sensitive markingmay be present within a portion of the field of view of the sensor whenthe sleeve is attached, or it may extend over the entire field of view.In some variations, the system may verify the newness of the sleeve bydetecting the use-sensitive marking and may actively or passively modifythe use-sensitive marking to indicate that the sleeve has been used.

Sleeve Structure

Any of the methods and apparatuses described herein may also beconfigured to include a sleeve in which the identifier corresponds toone or more physical features, such as notches, protrusions (e.g.,bumps, projections, etc.) on the sleeve, including in the sleeve window,such as the periphery of the sleeve window, that may be within the fieldof view of the intraoral scanner when the sleeve is attached, and maytherefore be detected by the intraoral scanner. For example, one or morephysical features may be formed or added to the sleeve itself in theareas exposed to the camera, as shown in FIG. 6. In this example, thefeatures are miniature protrusions or bumps 605 on the edges of theopening of the sleeve window 611. Information about the sleeve may beencoded in the number, size and/or positions of the features (e.g.,notches, bumps, protrusions, etc.).

In any of the methods and apparatuses described herein, the apparatusmay automatically identify if the sleeve is new or used. In somevariations, as described above, this may be determined by comparing thesleeve identity (e.g., based on an identifier) and comparing it to alocal and/or remote database including information about the identifiedsleeve. Alternatively or additionally, the sleeve may include ause-sensitive materials and/or markings, as described above. Thus, anyof the apparatuses, including intraoral scanning systems and/or sleeves,described herein may be configured to automatically identify when asleeve is new or has been previously used. In some variations, this maybe part of the authentication of the sleeve and may modify the operationof the use of intraoral scanner, which may require a new sleeve witheach patient (e.g., at the start of the patient scanning session). Insome variations this may include authentication of a sleeve based on thesleeve identifier (e.g., number, symbol, alphanumeric, QR code, barcode, etc.) to confirm that this sleeve is new and unused based on aremote central server/database and/or a local server/database. Any ofthese systems may communicate use and other information about anidentified sleeve to the local and/or remote sleeve database (e.g., aserver maintaining the sleeve database).

As mentioned above, any of these systems may be configured to use theimaging properties of the intraoral sensor (e.g., wand) to confirm theauthenticity, newness and/or validity of a sleeve. In particular, any ofthese system may be configured to use the distance of the sleeve window(and/or any marking thereon). For example, the system may confirm thatan identifier is present in a target location, corresponding to theinner and/or outer surface of the sleeve window. In variations includingan identifier, the identifier may be on an inner and/or outer surface ofthe sleeve window.

In any of the apparatuses described herein, the intraoral scanner mayinclude one or more electronic agents, in software, firmware, and/orhardware, to assist in authentication and confirming that a sleeve isnew and/or is approved for use with the intraoral scanner.

Single Use, Reuse and/or Multiple Use

As described above, in any of the variations described herein thesystems and/or sleeves described herein may be configured for single,one-time (e.g., one continuous session) or a limited duration of timeuse. For example, a system may be configured to identify a sleeve by anyof the techniques described herein and may restrict us of the system(e.g., scanning) to a single session and/or a limited duration. Thesystem may include a processor that, upon determining the identity ofthe sleeve, may limit the use of the identified sleeve to a singlecontinuous session in which the same patient is being scanned. Thesession may be determined by the scanning of a single patient without apause in scanning of more than some predetermined amount (e.g., 5minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, etc.).In some variation the session is based on the identity of the patient(e.g., a session ends, requiring a new or newly cleaned sleeve, when adifferent patient is scanned). The patient identity may be any uniqueidentifier corresponding to a patient, including number, chart number,name, etc.

Any of the sleeves and/or systems described herein may be configured toallow and/or detect cleaning of the sleeve so that it may be reused.Cleaning may include sterilizing. For example, the sleeve may besterilized by any appropriate technique, including autoclaving, washing,etc. In some variations the identified may be configured to include anidentifier that changes after cleaning (and/or sterilizing). Forexample, the indicator may include a compound that reacts to change(e.g., color, shape, etc.) after exposure to heat within the range ofthe autoclave. For example, a material such as copper thiosulfate(yellow) changes color (e.g., to a black copper sulfide) understerilization conditions, typically heat greater than 121 degrees C.Other composition may be barium salts, etc.

Alternatively or additionally the system may mark the sleeve during orafter use, e.g., by exposure to light, which may modify a use-sensitivematerial as described above. In some variations this use-sensitivematerial may be reset by the cleaning (e.g., sterilizing) process. Insome variations the sleeve may be marked (e.g., using a light-sensitivematerial) to indicate a number of uses. For example, a light-sensitivematerial may be exposed to a pattern resulting in a marking that may bedetected for each use, allowing the number of uses to be indicated andread by the system; after a predetermined number of uses the sleeve maybe identified in the local and/or remote system as expired or otherwiseprevented from further use.

Window Cover

According to some embodiments, the sleeve includes a protective windowcover that covers the window, for example, when the intraoral scannerwand is not being used to scan the patient's dentition. The window covermay protect the window from damage (e.g., scratching) during storage,transport and/or handling of the sleeve. Once the window cover isremoved, the window is revealed and ready for use by the scanner. Thewindow cover may also be used as an indicator to signify whether thesleeve has been used or is unused. For example, a sleeve with a windowcover may indicate that the sleeve has not been used, while a sleevewithout a window cover may indicate that the sleeve has been used. Thewindow cover may be attached to the exterior surface and/or the interiorsurface of window of the sleeve. In some cases, the window cover isconfigured to be removed from the sleeve before the sleeve covers thewand. In other cases, the window cover is configured to be removed fromthe sleeve after sleeve covers the wand.

FIGS. 8A-8B illustrate examples of sleeves with window covers. FIG. 8Ashows a sleeve 809 that includes a window cover 813 (e.g., adhesivesticker) adhered onto the exterior surface of the window 811. Asdescribed herein, the sleeve body can define an opening where the windowis supported within. In the embodiment shown, the window is recessedwith respect to a frame portion 805 of the sleeve body that frames thewindow. In some cases, the window cover covers at least a portion of theframe portion 805. In other embodiments, the window cover substantiallyonly covers the window. The sticker may include a tab 821 for easyremoval from the window.

FIG. 8B shows a sleeve 859 having similar features as the sleeve of FIG.8A, except that the window cover 863 is coupled to the frame portion 855of the sleeve body that frames the window 861. In some embodiments, thewindow cover is not adhesively coupled to the exterior surface of thewindow. In some cases, the window cover 863 is frictionally attached(e.g., friction fit) and/or adhesively adhered to the interior edges ofthe frame portion 855. The window cover may be rigid (e.g., made of arigid polymer material) to facilitate a friction fit. In other cases,the window cover 863 is compliant (e.g., made of a flexible polymermaterial) that conforms to the edges of the frame portion 855 of thesleeve body and/or the window. The window cover may include a tab 871 tofacilitate removal of the window cover from the sleeve body.

As described herein, the one or more identifiers can be located anywhereon the sleeve, such as within the window area as shown in FIGS. 5A-5C.In some embodiments, the identifier(s) is/are located on a window cover,as shown in the examples of FIGS. 8A and 8B. In particular, identifier807 is on the window cover 813 of FIG. 8A, and identifier 857 is on thewindow cover 863 of FIG. 8B. The identifier may be on a separate layer(e.g., sticker) that is adhered onto the window cover with theidentifier printed or otherwise disposed thereon. Alternatively oradditionally, the identifier may directly applied (e.g., printed on,etched, molded onto, etc.) onto the window cover. In the examples ofFIGS. 8A-8B, the identifiers include a QR code. However, theidentifier(s) can have be in any form, as described herein. Forinstance, the identifier(s) may alternatively or additionally include analphanumeric code, a logo, a symbol, a bar code and/or a mark.

Having the identifier separable from the sleeve body can have severaladvantages. For example, since the identifier can be removed once it isscanned by the intraoral scanner (wand), the identifier cannot beinadvertently scanned or otherwise interfere with the scanning of thepatient's teeth. Thus, there is no need to hide the identifier or makethe identifier discrete from the field of view of the scanner. Thisallows the identifier to be large as needed for easy detection by thewand without interfering with the tooth scanning procedure. Theidentifier may be disposed on other separable portions of the sleeveother than a window cover, thus providing the advantages describedabove. For example, the identifier may be on a removable sticker on adifferent part of the sleeve body (other than the window), which can beseparated from the sleeve body once scanned.

Scanner Use Mode

As described herein, the identifier may encode information about asleeve, such as the sleeve type, use status, batch, serial number,designation and/or other characteristics about the sleeve, which can bescanned and authenticated by the intraoral scanner. In some cases, theinformation from the identifier may dictate one or more operations ofthe scanner. As described herein, the intraoral scanning system may beconfigured to unlock once the identifier is authenticated, therebygiving access to the scanning system. Conversely, the intraoral scanningsystem may be configured to lock (e.g., turn off) if the identifier isdetermined not to be authentic. This way, the identifier may block theuse of invalid sleeves that would otherwise cause cross-contamination,reduce the scan quality, and/or degrade the quality of the practitioneror patient experience. As described herein, the identifier may beconfigured for single use to prevent the use of a particular sleeve onceit has already been used. The single use model may also prevent the useof duplicate (“fake”) identifiers.

In some embodiments, the identifier information is used to set a usemode of the intraoral scanner. A use mode can refer to the variousscanner parameters/settings accessible while the scanner is use. Thescanner may be designed to operate in more than one use mode, with eachuse mode allowing access to different scanning parameters/settings. Anyof the scanner use modes described herein may be automatically set bythe scanning system, for example, once the identifier is authenticated(or unauthenticated) by the scanning system. For example, the scanningsystem may automatically unlock once the identifier is authenticated, orautomatically lock once the identifier is identified as unauthentic. Insome cases, the scanning system is configured to provide one or moreindicators (e.g., what used mode the scanner is in). For example, thescanning system may provide a message on the display (FIG. 1, 105)and/or an audible alarm.

The use mode can be set based on particular characteristics of thesleeve. For example, some sleeve types may be designed for use withcertain types of scanning procedures but not others. The use mode can beset based on the compatibility of the sleeve with the scanner. Forexample, some sleeves may only be compatible to operate with certaintypes/models of scanners and not others. In some cases, different usedmodes allow the scanner to operate in one or more different scanningmodes (e.g., optical wavelengths, fluorescent wavelengths, and/or nearinfrared imaging (NIRI) wavelengths).

The use mode can be set based on the type of sleeve. For example, theidentifier information may define whether the user is allowed tointerrupt a scan (e.g., to remove the sleeve for cleaning) and tocomplete the scanning process using the same sleeve. This kind ofpermission may be useful for removable sleeves that are designed to becleaned between scanning procedures rather than being disposed of.

In some cases, the use mode is associated with the customer using theintraoral scanner. For example, different customers may desire access todifferent modes/levels of scanning operations. Thus, the identifier onthe sleeve can convey such information to the scanner and the scanningoperating parameters are set accordingly. This scheme can allow for apay per scan implementation or other customized use setting based on apre-arranged agreement, thereby providing more flexibility forcustomers.

Methods of Use

FIG. 7 illustrates one example of a method 700 of operating an intraoralscanner by determining a user parameter of a sleeve and adjusting theoperation of the intraoral scanner accordingly. For example, asillustrated in FIG. 7, the method may include detecting a user parameterwith the intraoral scanner 701. The use parameter may be an identifierthat is associated with the sleeve, including uniquely associated withthe sleeve. In some variations the use parameter is a directly detecteduse-sensitive material, such as a composition that is modified inresponse to use of the sleeve by an intraoral scanner. The use parameter(e.g., identifier) for the sleeve may be detect as illustrated anddescribed above, typically by scanning or otherwise receivinginformation associated with the sleeve using the wand of the intraoralscanner. For example, the wand may optically detect (image) thesurface(s) of the sleeve window. This step may be performed before,during or after attaching the sleeve to the wand.

The use parameter may then be used to verify that the sleeve is unusedand/or that the sleeve is authenticated for use with the intraoralscanner 703. This may include using a processor of the intraoral scannerand/or a remote processor/database in communication with the intraoralscanner to confirm the identity of the sleeve and any trackinginformation about it (used, expiration, category, lot, zone of approveduse, etc.). In some variations the use parameter may include informationabout the modification to the intraoral scanner for use specific to thesleeve.

Thus, the method may include modifying the operation of the intraoralscanner until the verification confirms that the sleeve is unused and/orauthenticated for use with the intraoral scanner 705. The intraoralscanner may be modified by suspending operation (scanning) of a patientuntil a new sleeve is detected. One or more user interfaces may be usedas part of any of these steps, including providing user instructions foruse.

FIG. 10 illustrates another example of a method 1000 of operating anintraoral scanner. An identifier on a removable protective sleeve isscanned using a wand of the intraoral scanner 1001. In some variationsthe sleeve is scanned after being applied onto the wand. In somevariations the sleeve is scanned prior to being applied (e.g., attached,worn over, etc.) the wand. This identifier can include encodedinformation related to the sleeve, such as the status of the sleeve(e.g., used or unused), model number (e.g., indicating compatiblescanners), batch number (e.g., indicating manufacturing process),customer number (e.g., indicating a purchasing history) and/or otheridentifying information. In some embodiments, the identifier is on, orpart of, a removable portion of the sleeve that can be removed prior toperforming a scanning operation on the patient's dentition. For example,the identifier may be on, or part of, a window cover that covers andprotects the sleeve window prior to use.

The sleeve identifier can be used to set a used mode of the intraoralscanner 1003. For example, the identifier can include authenticationinformation indicating that the sleeve is suitable for use with thescanner, thereby unlocking one or more scanning operation modes of thescanner. If the identifier may include sleeve status information (e.g.,used or unused), this information can also be used to lock or unlock oneor more scanning operation modes of the scanner. If the identifierincludes information related to compatibility with certain types ormodels of scanners, this information can be used to lock operation ofthe scanner except for use with those sleeves determined to becompatible.

In some variations, once the identifier of the sleeve is scanned, thewand of the intraoral scanner can be covered with the sleeve 1005 inorder to protect the patient from cross-contamination. Note that in somevariations the sleeve may be scanned after it is placed on the wand(e.g., through the window), as described herein. If the identifier is ona removable portion of the sleeve, the identifier can be removed fromthe sleeve. This can be done prior to the sleeve being placed on thewand of the scanner, or after the sleeve is place on the wand of thescanner. In embodiments where the identifier is on (or part of) a windowcover, the window cover (with the identifier) can be removed from thewindow to reveal the sleeve window. The patent's dentition can then bescanned using the sleeve-covered wand 1007.

Examples

In some variations authentication includes authentication of a sleevebased on packaging associated with the sleeve. For example, FIG. 11Aillustrates one example of a method of authenticating a sleeve for usewith an intraoral scanner 1103 using the intraoral scanner itself,including a wand or hand-held portion of the intraoral scanner, to scanan identifier (e.g., code, such as a QR code, bar code, etc.) 1107 onthe packaging enclosing one or more sleeves. In FIG. 11A, the box 1101includes a plurality of, e.g., n, sleeves. In some variations the QRcode may be scanned by the intraoral scanner, which may permit theintraoral scanner to operate for n scans (e.g., one scan per sleeve). Asmentioned, in in some variations the code may enable oral cavityscanning by the intraoral scanner, and may therefore disable or suspendintraoral scanning until authentication by a valid code.

In some variations the identifier 1107 may also or alternativelyindicate information about the sleeve(s) within the box, such asmaterial properties, optical properties, expiration date, countryverification code, etc. Scanning the identifier 1107 may modify theoperation of the intraoral scanner by enabling/disabling operation ofthe intraoral scanner, modifying the optics of the intraoral scanner(e.g., intensity, wavelength, scan rate, etc.), and/or displaying one ormore messages to the user (e.g., dental professional). For example, theintraoral scanner optics may be matched to the optics of the sleevewindow based on the information from the identifier. In some variationsthe authentication identifier (e.g., code) may be used to verity thatthe sleeve is compatible with the region (e.g., based on region). Adisplay may inform the user that the sleeve is authentic and/orcompatible with this region or that is not compatible and/or notauthentic. In some variations the intraoral scanner may determine that,based on the identifier, the sleeve is appropriate for the country orother jurisdiction in which the scanner is being operated; in somelocations regulations regarding the use of the sleeve and intraoralscanner may be different, and the system may indicate that indicate thetype of sleeve is appropriate or not appropriate for the specificlocation in which the intraoral scanner is located. For example, someregions may require that the intraoral scanner be used with a sleevethat extends longer than 14 inches, whereas other regions may allowsleeves that extend only to 12 inches. In some variations the sleevemust be made of a particular material, etc. The authenticationidentifier may include this information within the identifier, or it mayrefer to a reference (e.g., look up table, database, either remote orlocal to the intraoral scanner) to determine compatibility. The systemmay include an output indicating one or more messages and/or may lockout the user from using sleeves that are indicated as not appropriatefor a particular region or device, or may simply provide a warning.

FIG. 11B shows another example of a system and method of operating anintraoral scanner with authentication as described herein. In FIG. 11B,the intraoral scanner 1103 may be used to scan an identifier 1107′ onthe outside (or in some variations the inside) of a container 1105,e.g., packaging, holding a single sleeve. As mentioned, the identifiermay be one or more of: an alphanumeric code, a logo, a symbol, a QRcode, a bar code, etc. Alternatively or additionally, an identifier(e.g., authentication code) may be packaged with the sleeve, e.g., on aninsert, paper or other accompanying material.

As mentioned above, in some variations one or more authenticationidentifiers may be included on the sleeve itself. FIG. 12A shows anexample in which the identifier 1207 (shown in this example as a QRcode) is on the outside of the sleeve and is scanned by the hand-heldwand of the intraoral scanner 1203. After scanning, the intraoralscanner wand may be placed into the sleeve 1206 so that the two engageand the optics of the intraoral scanner line up with the window (notvisible in FIG. 12A) of the sleeve.

Alternatively or additionally one or more identifiers may be included inthe inside of the sleeve 1206′, as shown in FIG. 12B. In FIG. 12B, thewand of the intraoral scanner 1203 is slid into the sleeve 1206′, asshown by the arrow 1215, so that the sleeve may engage with theintraoral scanner. In this example, the identifier is adjacent to thewindow 1208 region on the inside of the sleeve so that the intraoralscanner scans it as it is inserted into the sleeve. The intraoralscanning system may automatically identify the identifier (e.g., code1207′) and the identifier may then modify the activity of the intraoralscanner as described herein.

For example, in some variations of the methods and apparatuses (e.g.,systems) described herein, the intraoral scanner may be configured sotthat it is turned on to allow scanning, and in particular scanning ofthe identifier on a sleeve or sleeve packaging, in a first mode ofoperation. This mode of operation may be timed (e.g., the intraoralscanner may allow scanning for a period of time that is sufficient toscan the identifier, patient face, user face, chart, etc.) but may notbe on long enough to scan the dentition. This first mode (e.g., theauthentication mode or sleeve authentication mode) may be limited toscanning in a manner that does not permit (pending an override by theuser) of the teeth. This may prevent operation of the intraoral scannerin a manner that is contrary to safety or public policy (e.g., withoutthe protection of a sleeve. Once the system detects a sleeve andauthenticates the sleeve as described herein, the intraoral scanningsystem may switch to a second (intraoral scanning, orpost-authentication) mode in which the patient's oral cavity may bescanned, displayed, and/or saved as part of a patient file.

The authentication step, in which the authentication code is identifiedand reviewed either locally and/or remotely (if communications, such asinternet communications, are available) may modify the operation of theintraoral scanner, including allowing a transition between theauthentication mode of operation and the intraoral scanning mode, and/orenabling certain functions of the intraoral scanner or processing of thescan data.

In some variations the sleeve identifier may be tied to a processingcode that indicates to the intraoral scanning system how the patientscan should be processed. For example, in some variations sleeves may bemarked as part of the identifier (e.g., code, etc.) for use ingenerating a particular orthodontic and/or dental model or program, suchas for generating a series of dental aligners to move teeth. Theidentifier (e.g., code) on the sleeve may cause the intraoral scanner toprocess the intraoral scan either during scanning (e.g., confirming thatthe scan data is appropriate for modeling the patient's dental arch forthe procedure(s) indicated on the sleeve identifier, and/or forpost-scan processing, e.g., transmitting the scan for generating adental treatment plan as indicated by the sleeve identifier. Identifier(e.g., codes) on sleeves may therefore include promotional codes(including pricing and discount information). In some variations theidentifier may cause the intraoral scanning system to generate userinterfaces that are specific to one or more identified procedures or thelike.

In some variations the intraoral scanning systems described herein maybe configured to identify when the sleeve is being applied and/orremoved. For example, in the variation shown in FIG. 12B, if theintraoral scanner is in a scanning mode and the intraoral scannerdetects the identifier (e.g., QR code 1207′) the system may infer thatthe sleeve is being removed. In this case the intraoral scanner mayswitch into a post-scanning mode, and/or back into an authenticationmode.

FIG. 12C shows another example of a sleeve 1206″ in which a pair ofidentifiers 1212, 1218 are included within the inside of the sleeve. Inthis example, the scanner 1203 may sequentially scan these identifierswithin a reasonable time window (e.g., a few seconds, a minute, etc.)and the order in which the two identifiers are scanned may indicate ifthe sleeve is being placed onto the intraoral scanner or being taken offof the intraoral scanner. For example, if the intraoral scanner passesthe first identifier 1212 before the second identifier 1218, then it islikely that the sleeve is being placed onto the intraoral scanner 1203.The first and second identifiers are therefore typically different andmay be different colors, patterns, alphanumerics, logos, etc. In somevariations the first and/or second identifiers may also encodeinformation as described herein. In any of these variations, the system(e.g., the intraoral scanner) may count the number of times a sleeve isplaced on/taken off.

In variations in which the sleeve may be reused (e.g., with the samepatient), the intraoral scanner may identify the number of uses and/ormay limit the number of uses. In some variations the system may promptthe user to confirm that the sleeve has been sterilized or cleaned; theintraoral scanner may uniquely identify that the sleeve has been usedbefore (either on the same intraoral scanner or a different intraoralscanner). In some variations the system may confirm, based on theidentifier and patient-specific identifying information, either manuallyor automatically entered about the patient, including the patient nameor other unique identifier.

As mentioned, any of the apparatuses (e.g., intraoral scanning systems)described herein may be configured to confirm that a sleeve, or in somecases a sleeve of the appropriate type, model, batch, etc., or a “new”(unused) sleeve, is being used. In some variations the apparatus may beconfigured to prevent operation in the oral cavity scanning mode ifthere is no sleeve on, or if the sleeve is not appropriate.

The examples provided above (e.g., in FIGS. 11A-12C) are opticalauthentication systems and methods, in which the identifier is opticallyscanned, preferably the existing scanning components of the intraoralscanner that will be used to scan the teeth and other parts of theintraoral cavity. Is some variations one or more non-optical identifiers(and detectors) may be used, such as radio frequency (RF) tags (e.g.,RFIDs), ultrasound, nearfield, Bluetooth, etc. These authenticationidentifiers and/or detectors may be present on sleeve and/or wand. Forexample, FIG. 13 shows a variation in which an RFID tag 1315 is includedas part of the sleeve (e.g., on an inside or outside of the sleeve) andthe intraoral scanner (e.g., wand 1303) includes an RFID reader 1305, asshown. This may be used in addition or optical scanning.

As described above, in some variations you may run the intraoral scannerprior to engaging the sleeve, in order to detect and authenticate thesleeve by scanning the identifier (e.g., code). This scanner maytherefore be operated in a pre-scanning (e.g., authentication) modeuntil authentication is complete. In some variation the scanner may beattached to the sleeve without scanning first. Once the sleeve isattached over the intraoral scanner may be operated to detect thesleeve. For example in variation in which an identifier is present onthe window of the sleeve (or as a removable decal over the window) theintraoral scanner may immediately detect and react to the identifier. Insome variations, such as when the identifier is present on the inside oroutside of the sleeve the intraoral scanner may be removed from thesleeve, the identifier scanned, and the sleeve reapplied. In somevariations, as when the identifier is partially within the sleeve, thesleeve may be partially removed, and the identifier scanned as it ispartially removed; the intraoral scanner apparatus may indicatesuccessful authentication (or at least successful identification of theidentifier), and the sleeve immediately reapplied.

In some variations the identifier may be used to limit the time that thesame sleeve may be used with an intraoral scanner. For example theidentifier may uniquely identify the sleeve and the intraoral scannersystem may time how long the sleeve is used for before it is removed.Once removed the identifier associated with the sleeve may be set (e.g.,within a local and/or remove database accessible by the intraoralscanner) indicating that the sleeve has been used (or the number oftimes that it's been used). Further, as mentioned, the intraoral scannerapparatus may “time out” a sleeve after it has been used for apredetermined, or in some cases selectable, time period. In somevariations the intraoral scanner may be configured to prevent the samesleeve from being used with a different patient. For example, if theuser changes to another patient record, the intraoral scanner apparatusmay require a new sleeve based on the authentication identifier and/or apreviously used sleeve that was previously used with that patient. Insome variations, as mentioned above, the apparatus may detect that thesleeve has been sterilized and/or may prompt the user to confirm thatthe same sleeve, based on the identifier, has been sterilized.

The information that may be encoded and/or associated with theidentifier (e.g., identification code), as mentioned above, may includea unique identifier (number, alphanumeric, etc.) that may be specific tothe sleeve, and/or specific to a type, class, lot, batch, etc. ofsleeve(s). In some variations, as mentioned above, the sleeve identifiermay include or be associated with a region code. In some variations theidentifier includes information or is associated with informationregarding the lot number, an expiration date, a region code, a practicecode, a promotional/marketing code, a procedure code (e.g., alignersleeve, infrared sleeve, palatal expander sleeve, caries detectionsleeve, etc.), a recall code, etc.

As mentioned the code may itself include/encode any of the informationdescribed above, or it may be associated either locally (e.g., in alocal memory on an intraoral scanner) and/or remotely (e.g., on databasethat one or more intraoral scanners connects to continuously and/orperiodically). An identifier may be “associated” with information in anumber of ways. For example, the identifier or a portion of theidentifier may be used as an index to a look-up table or databasecontaining information about one or more of these classes of informationthat is linked to the identifier.

For example, FIG. 14 shows one example of an intraoral scanning system1410 as described herein, including a hand-held intraoral scanning wand1403 and an intraoral scanning processor 1411. In FIG. 14 the two areshown as separate and connected by a cord; alternatively the intraoralscanner processor 1411 may be coupled wirelessly to the wand 1403 and/ormay be integrated completely or partially into the wand (not shown). Theintraoral scanner processor 1411 may include a controller (e.g., controlcircuitry) 1413, an authentication decoder 1415, and a local datastoreor database 1417. The intraoral scanner processor may include a numberof other modules, including optical control (imaging) modules, scanningcontrol modules, inputs (e.g., user inputs, buttons, keyboards, etc.)and outputs (e.g., displays, LEDs, audio outputs, etc.), not shown inthis figure. In general, one or more of these apparatuses 1410 may be incontinuous or period (hourly, daily, weekly, monthly, etc.) and/orintermittent (e.g., on demand, irregular, etc.) communication with aremote server 1421, including a remote database 1427. The remote servermay provide updates to the local database 1417 and/or authenticationdecoder 1415 and/or controller 1413. For example the intraoral scannermay pass patient scan data on to the remoter server for furtherprocessing.

In use, the intraoral scanner may authenticate a sleeve 1401 asdescribed above, including using the wand of the intraoral scanner 1403with imaging optics for imaging the intraoral cavity, and apply theseimaging optics to scanning the identifier on the sleeve 1401. Asmentioned, the intraoral scanner may be held in a pre-authenticated modeprior to authentication, which may limit the functioning of theintraoral scanner 1410 until authenticated. Once the intraoral scanner(e.g., wand 1403) scans the identifier on or associated with a sleeve(or group of sleeves) the identifier may be processed by theauthentication decoder 1415 to parse and/or interpret/apply theidentifier and authenticate the sleeve. An authentication decoder may bemodule, and may include hardware, software and/or firmware for parsingthe identifier. The authentication decoder 1415 may use the imaging datafrom the scan(s) being taken (typically at a high rate) and process theimages (or groups of images) and extract from the image(s) theauthentication identifier. This identifier may then be interpreted bythe authentication decoder, including by using the local database 1417to look up information (and in some variations control instructions)associated with the identifier. In some variations the authenticationdecoder may pass information and/or instructions based on the decodedidentifier on to the controller for controlling operation of theintraoral scanner, including authenticating the sleeve and entering intoan intraoral scanning mode, locking the intraoral scanner to preventscanning until authentication, displaying user information, instructionsand/or user interface(s), modifying the operation of the optics, lightsources, scanning control, oral cavity reconstructions, etc., based onthe identifier.

The architecture shown in FIG. 14 is one variation of an intraoralsystem. Other variations may be used. For example, in some variationsauthentication and control is limited to just local operation (e.g., theauthentication decoder and/or local database may not communicate with aremote server). Alternatively in some variations, the system iscontinuously linked to a remote server (or semi-remote server, which maycommunicate locally with multiple intraoral scanners, e.g., in a clinicor office); in this configuration the individual intraoral scanner maynot include an authentication decoder and/or local database, or mayinclude only a simplified authentication decoder and/or local database,and instead may transfer more rigorous decoding of the identifier to theremote or semi-remote servers. In some variations the intraoral scannerdoes not include a database (e.g., look-up database). The intraoralscanner architecture shown in FIG. 14 may be particularly beneficial insituations.

Any of the methods (including user interfaces) described herein may beimplemented as software, hardware or firmware, and may be described as anon-transitory computer-readable storage medium storing a set ofinstructions capable of being executed by a processor (e.g., computer,tablet, smartphone, etc.), that when executed by the processor causesthe processor to control perform any of the steps, including but notlimited to: displaying, communicating with the user, analyzing,modifying parameters (including timing, frequency, intensity, etc.),determining, alerting, or the like.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

In general, any of the apparatuses and methods described herein shouldbe understood to be inclusive, but all or a sub-set of the componentsand/or steps may alternatively be exclusive, and may be expressed as“consisting of” or alternatively “consisting essentially of” the variouscomponents, steps, sub-components or sub-steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A method of operating an intraoral scanner, the method comprising: scanning, using a wand of an intraoral scanner, an identifier associated with a sleeve configured to be worn on a wand of the intraoral scanner; verifying that the sleeve is authenticated for use with the intraoral scanner based on the identifier; and modifying operation of the intraoral scanner based on the identifier.
 2. The method of claim 1, wherein modifying operation of the intraoral scanner comprises limiting the intraoral scanner from scanning a subject's dentition until the verification confirms that the sleeve is unused and/or authenticated for use with the intraoral scanner.
 3. The method of claim 1, wherein scanning is performed when the sleeve is attached to the wand using the wand of the intraoral scanner to scan the identifier on a window through the sleeve.
 4. The method of claim 3, wherein the identifier is on a portion of a window that is within the field of view of the intraoral scanner.
 5. The method of claim 1, wherein scanning comprises scanning an outside of the sleeve.
 6. The method of claim 1, wherein scanning comprises scanning an inner surface within the sleeve.
 7. The method of claim 1, wherein scanning comprises scanning the identifier as the sleeve is attached to the wand.
 8. The method of claim 1, wherein verifying that the sleeve is authenticated comprises confirming that the sleeve is unused.
 9. The method of claim 1, wherein verifying that the sleeve is authenticated comprises looking the identifier up in a database to confirm that the sleeve associated with identifier is approved for use with the intraoral scanner.
 10. The method of claim 1, wherein verifying that the sleeve is authenticated comprises looking the identifier up in a remote database to confirm that the sleeve associated with identifier is approved for use with the intraoral scanner.
 11. The method of claim 1, wherein verifying that the sleeve is authenticated comprises examining a use-sensitive material of the identifier to confirm that the sleeve is unused.
 12. The method of claim 1, wherein scanning comprises examining a surface of a window through the sleeve.
 13. The method of claim 1, wherein modifying comprises suspending operation of the intraoral scanner.
 14. The method of claim 1, wherein modifying comprises preventing scanning of a patient's dentition with the intraoral scanner until the sleeve is confirmed as unused and/or authenticated for use with the intraoral scanner.
 15. The method of claim 1, further comprising updating a database with a use status of the sleeve indexed by the identifier.
 16. A method of operating an intraoral scanner, the method comprising: scanning, using a wand of the intraoral scanner, an identifier of a sleeve, wherein the identifier is located on a sleeve; verifying that the sleeve is authenticated for the intraoral scanner based on the identifier; and preventing the intraoral scanner from scanning the patient's dental arch until the verification confirms that the sleeve is authenticated.
 17. A method of operating an intraoral scanner, the method comprising: scanning, using a wand of the intraoral scanner, an identifier on a sleeve, wherein the sleeve is configured to cover an exterior surface of the wand with the sleeve such that a window of the sleeve is in a field of view of the wand, the identifier including information associated with one or more characteristics of the sleeve; automatically setting a particular use mode of the intraoral scanner based on the scanned identifier information, wherein the particular use mode dictates one or more scanning parameters of the intraoral scanner and is one of a number of different use modes of the intraoral scanner; and scanning a patient's dentition with the covered sleeve while the intraoral scanner is set in the particular use mode.
 18. The method of claim 17, wherein determining the use mode includes determining a whether the sleeve has been used or is unused.
 19. The method of claim 17, further comprising removing the identifier from the sleeve prior to scanning the patient's dentition.
 20. The method of claim 17, further comprising limiting the intraoral scanner from scanning a subject's dentition until the scanned identifier information confirms that the sleeve is unused and/or authenticated for use with the intraoral scanner. 